AAC Intervention for Intellectual Disability

Overseen By Alexandria Cook, B.A.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Uncontrolled seizure disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 32

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a communication method called Augmentative and Alternative Communication (AAC) to help toddlers with intellectual and developmental disabilities (IDD) improve language skills. The study aims to determine if this method enables caregivers to use communication strategies more effectively, enhancing communication for the children. It targets families with toddlers who have IDD, severe developmental and language delays, and have been receiving early intervention services. The trial includes both in-person and telehealth sessions to teach caregivers how to use AAC. As an unphased trial, it offers families the chance to explore innovative communication strategies that could significantly enhance their child's language development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this AAC intervention is safe for toddlers with intellectual and developmental disabilities?

Research has shown that Augmentative and Alternative Communication (AAC) methods are generally safe. These methods aim to help children with intellectual and developmental disabilities (IDD) enhance their communication skills. Although specific safety data for this AAC method is unavailable, AAC typically involves teaching new communication techniques, which pose no physical risk.

AAC aids children in developing better communication skills and has been shown to increase communication, improve language and reading skills, and reduce negative behaviors. As these methods are non-invasive and focus on enhancing behavior and communication, they are well-received. Families often find them helpful and easy to integrate into daily life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Augmentative and Alternative Communication (AAC) Intervention for intellectual disabilities because it offers a fresh approach to enhancing communication skills in children. Unlike traditional methods that often rely on speech therapy or behavioral interventions, this treatment directly integrates AAC tools early in development, aiming to improve parent-child interactions more rapidly. By focusing on early intervention, this approach may help children with intellectual disabilities develop communication skills sooner, potentially leading to better long-term outcomes.

What evidence suggests that this AAC intervention is effective for improving communication in toddlers with intellectual and developmental disabilities?

Research has shown that AAC (augmentative and alternative communication) methods can effectively help children with intellectual and developmental disabilities (IDD) communicate better. These methods assist by adding to or replacing speech and understanding when difficulties arise. A review of several studies found that AAC methods improve language and communication skills in children who struggle with speaking and understanding language. These benefits increase when caregivers participate, indicating that training caregivers in AAC techniques can lead to better results for children. Overall, AAC offers a promising way to improve communication for children with IDD.

In this trial, participants will receive the Early Augmentative and Alternative Communication (AAC) Intervention to assess its effectiveness in enhancing communication skills in children with IDD. ^{1 3 5 6 7}

Who Is on the Research Team?

Emily D. Quinn, Ph.D.

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for toddlers aged 24-36 months with intellectual and developmental disabilities (IDD) who have severe language delays but can sit up, interact, and use AAC systems. Caregivers must be fluent in English, over 18 years old, and experienced in early intervention. Speech-language pathologists should also speak English fluently, have experience with AAC in children with IDD, and work full or part-time providing language intervention.

Inclusion Criteria

I am the main caregiver for a child aged 2 to 3 years with intellectual and developmental disabilities.

Children who have very limited ability to speak and communicate using words or gestures.

Criterion: Speech-Language Pathologists who work with at least one child who uses AAC.

Exclusion Criteria

My child's seizures are not controlled by medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Stable baseline performance is established for parent and child outcomes

3-5 sessions

Intervention Development

Development of AAC intervention through iterative testing cycles with in-person sessions

24 sessions

24 visits (in-person)

Pilot Testing

Pilot test of hybrid telehealth AAC intervention with a combination of in-person and telehealth sessions

24 sessions

8 visits (in-person), 16 visits (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after intervention

3-4 months

What Are the Treatments Tested in This Trial?

Interventions

• Early Augmentative and Alternative Communication (AAC) Intervention

Trial Overview The study tests an AAC intervention to improve communication in toddlers with IDD using a hybrid telehealth model. It involves interviews to tailor the approach based on caregiver preferences followed by pilot testing both in-person and via telehealth sessions to evaluate its effectiveness.

How Is the Trial Designed?

Group I: Early Augmentative and Alternative Communication (AAC) Intervention Experimental Treatment 1 Intervention

After a period of stable baseline performance (3 to 5 sessions) on parent and child outcomes, the interventionist will apply the early AAC intervention.

Early Augmentative and Alternative Communication (AAC) Intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Augmentative and Alternative Communication for:

• Intellectual and Developmental Disabilities (IDD)
• Autism Spectrum Disorder (ASD)
• Cerebral Palsy
• Other developmental disabilities

Approved in European Union as Augmentative and Alternative Communication for:

• Intellectual and Developmental Disabilities (IDD)
• Autism Spectrum Disorder (ASD)
• Cerebral Palsy
• Other developmental disabilities

Approved in Canada as Augmentative and Alternative Communication for:

• Intellectual and Developmental Disabilities (IDD)
• Autism Spectrum Disorder (ASD)
• Cerebral Palsy
• Other developmental disabilities

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Published Research Related to This Trial

A three-year intervention using augmentative and alternative communication (AAC) devices significantly improved communication, daily living skills, and socialization in five adolescents with severe intellectual disabilities who had previously shown little progress with traditional speech therapy.

The study highlights that AAC not only enhances communication abilities but also boosts social participation and self-esteem in individuals with severe linguistic impairments, providing valuable insights for clinicians working with this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentative and alternative communication in adolescents with severe intellectual disability: a clinical experience. Uliano, D., Falciglia, G., Del Viscio, C., et al.[2011]

The study identified 23 existing outcome measures used in Augmentative and Alternative Communication (AAC) services, but none adequately cover the comprehensive objectives of AAC provision, highlighting a gap in current assessment methods.

To address this gap, the AAC Therapy Outcome Measure (AAC TOM) was developed, incorporating principles from the International Classification of Functioning (ICF-WHO) and is currently being trialed in UK AAC services to better reflect the impact of service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing the therapy outcome measure for AAC services in the context of a review of other measures. Enderby, P.[2019]

Augmentative and alternative communication (AAC) methods have significantly advanced in the last decade, improving support for children with developmental and intellectual disabilities who have limited speech.

The article highlights the importance of empirical research and technological innovations in enhancing AAC, while also identifying key issues and future growth areas in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of research and practice in augmentative and alternative communication for children with developmental/intellectual disabilities. Wilkinson, KM., Hennig, S.[2022]

This longitudinal qualitative study involving seven participants over two years provides new insights into how individuals with communication disabilities experience and adapt to augmentative and alternative communication (AAC) devices, highlighting the dynamic nature of their expectations and identity changes over time.

The research emphasizes the importance of contextual and temporal factors in shaping outcomes from AAC, suggesting that clinicians can better support users by understanding these influences and engaging in conversations that address broader communication needs beyond just message delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using longitudinal qualitative research to explore the experience of receiving and using augmentative and alternative communication. Broomfield, K., Judge, S., Sage, K., et al.[2023]

AAC intervention research is crucial for understanding how different communication interventions affect users, families, and educational and vocational outcomes, emphasizing the need for planned and replicable studies.

The commentary highlights the complexities of AAC research and the importance of considering emerging trends to improve intervention practices and their broader impacts on the AAC community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The complexities of AAC intervention research: emerging trends to consider. Romski, M., Sevcik, RA.[2019]

A systematic review of 17 studies indicates that augmentative and alternative communication (AAC) interventions are effective for improving communication skills in children with autism, particularly in teaching them to make requests.

Despite the promising results, there is a need for more rigorous studies and a clearer understanding of how AAC fits into comprehensive autism intervention programs, as many researchers may overlook its importance for children with significant learning challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of augmentative and alternative communication for children with autism: current status and future trends. Iacono, T., Trembath, D., Erickson, S.[2020]

The forum discusses strategies for starting a clinical service aimed at improving communication between patients and healthcare providers, which is crucial for effective treatment.

A large-scale clinical trial demonstrated the implementation of augmentative and alternative communication (AAC) tools in an acute-care setting, highlighting their potential to enhance patient-provider interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forum on Augmentative and Alternative Communication in Acute Care. Hurtig, RR.[2021]

Speech-language pathologists (SLPs) recognize the importance of Augmentative and Alternative Communication (AAC) for children with severe/profound intellectual and multiple disabilities (S/PIMD), but they find its implementation complex and challenging, often relying on their individual clinical experiences for decision-making.

The preferences and involvement of the child's social network significantly influence SLPs' choices regarding AAC methods, sometimes even more than the child's own abilities, highlighting the need for family-oriented research in AAC interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentative and alternative communication with children with severe/profound intellectual and multiple disabilities: speech language pathologists' clinical practices and reasoning. Rensfeld Flink, A., Thunberg, G., Nyman, A., et al.[2022]

Augmentative and alternative communication (AAC) significantly enhances communication for individuals with autism spectrum disorder (ASD) who struggle with conventional speech, as supported by decades of research.

Current AAC technologies offer substantial benefits for people with ASD, highlighting the need for continued research to further improve communication and outcomes for these individuals and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAC Interventions for Individuals with Autism Spectrum Disorders: State of the Science and Future Research Directions. Ganz, JB.[2015]

A case report highlights the successful use of a speech-generating device by a 30-year-old woman with moderate intellectual disabilities and severe expressive language disorder, demonstrating that AAC can enhance communication even in adults with some speech abilities.

The findings challenge the misconception that older adults with disabilities cannot improve their language skills, emphasizing the importance of AAC interventions for fostering independence and self-determination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a speech-generating device to enhance communicative abilities for an adult with moderate intellectual disability. Cheslock, MA., Barton-Hulsey, A., Romski, M., et al.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05743439

Early Augmentative and Alternative Communication (AAC) ... The goal of this mixed methods study aims to develop and pilot test an augmentative and alternative communication (AAC) intervention for toddlers with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8009928/

Augmentative and Alternative Communication for Children ... A mega-review of literature reviews, systematic reviews, and meta-analyses on interventions using aided augmentative and alternative communication (AAC) ...

3. asha.org asha.org/practice-portal/professional-issues/augmentative-and-alternative-communication/?srsltid=AfmBOoraLRxKEp0F2FmcSdeykOVcfKpGsqfDbLsOSzrxAWjSKidjcc41

Augmentative and Alternative Communication (AAC) AAC is an area of clinical practice that supplements or compensates for impairments in speech-language production and/or comprehension.

4. tandfonline.com tandfonline.com/doi/full/10.1080/07434618.2025.2477694

Augmentative and alternative communication (AAC) ... The purpose of this systematic review (INPLASY protocol 3160) was to describe and critically appraise the existing research on AAC interventions for commenting.

5. karger.com karger.com/fpl/article/77/4/362/919261/Effects-of-Augmentative-and-Alternative

Effects of Augmentative and Alternative Communication ... While research shows that AAC intervention can effectively support communication from children with IDD, research on its impact on school ...

6. withpower.com withpower.com/trial/phase-language-disorders-6-2022-5d5c7

AAC Intervention for Intellectual Disability The research does not provide specific safety data for AAC interventions, but these interventions are generally considered safe as they involve communication ...

7. apps.asha.org apps.asha.org/EvidenceMaps/Maps/LandingPage/990772a6-9cd8-4203-a76c-6ccd91eac874

Augmentative and Alternative Communication (AAC) Children increased communication, improved language and literacy, and decreased negative behaviors. Adults enhanced their communication and ...